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This 8-Page Letter Was Sent to Roger Mcclellan, Charles Whalley, and the Committee on Publication Ethics on 10/12/2017

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This 8-Page Letter Was Sent to Roger Mcclellan, Charles Whalley, and the Committee on Publication Ethics on 10/12/2017 This 8-page letter was sent to Roger McClellan, Charles Whalley, and the Committee on Publication Ethics on 10/12/2017 Dear Editors of Critical Reviews in Toxicology, We are writing to ask that you retract the summary review article1 in the 2016 supplemental issue of Critical Reviews in Toxicology entitled "An Independent Review of the Carcinogenic Potential of Glyphosate." This supplemental issue was dedicated to reviewing the 2015 decision by an expert Working Group of the International Agency for Research on Cancer (IARC) to designate glyphosate, the active ingredient In Roundup weedkiller and many other herbicide formulations, as "probably carcinogenic to humans" (Group 2A). For the reasons described below, the summary review fails to comport with Taylor and Francis's publishing ethics and should be retracted for misconduct. The 2016 supplemental issue contained five review papers, consisting of a summary and four in-depth reviews in the areas of exposure; epidemiology; cancer in experimental animals; and mechanistic and other relevant data, that were written by expert panels overseen by Intertek, a consulting firm that was hired by the primary producer of glyphosate - Monsanto. All five reviews were very critical of lARC's assessment and were touted as "independent" in the main title of the supplemental issue. The declaration of interest (DOI) statement for the summary article2 included the statement: "[t]he Expert Panelists were engaged by, and acted as consultants to, Intertek, and were not directly contacted by the Monsanto Company. Funding for this evaluation was provided to Intertek by the Monsanto Company which is a primary producer of glyphosate and products containing this active ingredient. Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel[']s manuscripts prior to submission to the journal." This DOI fails to accurately describe the events that preceded the publication of the summary manuscript, as demonstrated by emails recently released in the context of a lawsuit brought against Monsanto by sufferers of non-Hodgkin lymphoma. These emails provide information on the nature of Monsanto's involvement and interaction with some members of the expert panel during the research and writing phase of the analyses that were ultimately published in the 2016 supplemental issue. Below are two excerpts of the DOI statement, followed by evidence that these statements did not accurately describe Monsanto's relationship to the summary manuscript. 1) "The Expert Panelists were engaged by, and acted as consultants to, Intertek, and were not directly contacted by the Monsanto Company." This statement is inaccurate and misleading. At least two of the expert panelists were contacted directly by Monsanto regarding this review article and were paid directly by, and acted as consultants to, Monsanto for this review specifically. This DOI fails to disclose that these expert panelists worked as consultants for, and were directly paid by, Monsanto. Emails released pursuant to litigation show that expert panelist Dr. John Acquavella invoiced Monsanto on August 31, 2015 for work relating to the "...glyphosate expert epidemiology panel."3 In the itemization of the invoice there were multiple references to the epidemiology panel. Dr. Acquavella billed Monsanto for research on numerous studies that were subsequently cited and discussed at length in the epidemiology expert paper/ and for drafting the expert panel report. Thus, contrary to the DOI, Dr. Acquavella was a consultant for and was in direct communication with Monsanto regarding this work. Expert panelist Dr. Larry Kier signed a consulting agreement with Monsanto on August 20, 2015 for work relating to a project entitled: "Glyphosate Expert Panel."5 The objectives of this panel included: "1. Review glyphosate articles and generate summary 2. Attend the Intertek Scientific & Regulatory Consultancy ("Intertek") Expert Panel Meeting either in person or via teleconference. 3. Support the genotoxicity and oxidative stress portion of Intertek and support generation of a panel draft manuscript on glyphosate genotoxicity and oxidative stress." Thus, contrary to the DOI, Dr. Kier was a consultant for and was in direct communication with Monsanto regarding this work. Internal correspondence between Monsanto employees confirmed both of these consulting agreements.6 Both Dr. Acquavella and Dr. Kier were co-authors of the summary review article. 2) "Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel[']s manuscripts prior to submission to the journal." This statement is false. At least one Monsanto employee, Dr. William Heydens, did extensive editing to the summary manuscript. He also applied pressure to make the overall tone of the article more critical of the I ARC than multiple authors were comfortable with, and to have the articles published on a timeline that would be advantageous to the company. Dr. Ashley Roberts, an Intertek employee who co-authored the summary review, was in direct contact with Dr. Heydens during the writing and editing phases of the summary article. Dr. Heydens reviewed and edited the summary manuscript at least twice after being emailed copies on two separate occasions by Dr. Roberts.7 8 In response to Dr. Acquavella's request to tone down the strident criticism of IARC, Dr. Heydens pushed to keep "inflammatory" language in the manuscript.9 And in an earlier draft of the manuscript, Dr. Heydens again tried to distort the messaging of the summary article by incorrectly asserting that IARC did not find glyphosate to pose a carcinogenic hazard.10 Some of the edits and suggestions that were made by Dr. Heydens ended up in the final manuscript. These were not neutral copy edits; these were edits that impacted the tone of the summary review and mischaracterized lARC's methodology and process in a way that was meant to cast doubt on its conclusions regarding glyphosate. Dr. Heydens also indicated his company's preference that the editing process move along quickly in order to keep to a timeline that Monsanto's management preferred,11 In a separate email, Dr. Heydens mentioned writing an introductory section for the expert panel supplemental issue and tells Dr, Roberts that he would run it by her for edits.12 Unfortunately, the draft section that Dr. Heydens wrote was not attached to the email, so it is unclear if, and to what extent, this ghostwritten section was adopted in - or influenced - the final summary manuscript. Although Dr. Roberts at Intertek was supposed to be overseeing and directing the expert panels, her communications with Dr. Heydens indicate that many of the major decisions regarding these manuscripts were vetted by Monsanto.13 Dr. Heydens proposed the order of authorship on the final manuscript,1,1 while Monsanto management initially insisted that two panelists who had made substantial contributions be inappropriately excluded from authorship because of their prior employment by Monsanto.1S These communications and edited manuscripts clearly demonstrate that Monsanto reviewed and edited the work product at issue, contrary to what was stated in the DOI. Taylor & Francis Has an Obligation to Maintain the Scientific Integrity of its Journals The DOI for the summary review article includes false, inaccurate, and misleading statements, and fails to disclose the important information that at least two of the expert panelists were engaged by Monsanto as consultants in addition to, or in lieu of, Intertek. These deficiencies violate Taylor and Francis conflict of interest guidelines, as clearly stated on the publisher’s website.16 This was not simply a case of inadvertent error or ignorance of the rules. Dr. Roberts, the Intertek officer who had "overall oversight responsibilities"17 for the project and was also a co-author on the summary review, was told explicitly the type of information that needed to be disclosed in the DOI. Dr. Roberts received emailed instructions from Critical Reviews in Toxicology editor Roger McClellan that the DOI must include information on how the authors were engaged for the project and that any review by Monsanto personnel must be disclosed.1S The five review articles are represented as being "independent" in the title of the supplemental issue. The DOI statement for the summary review assures readers that Monsanto had no influence on the content of the reviews other than indirectly funding the work through an "independent” third party. This is false, and the scientific community and public were misled. At least one Monsanto employee edited the summary manuscript, vetted proposed decisions by the ostensible editor in charge, Dr. Roberts, and also had direct contact with at least two of the expert panelists, all in direct contradiction to the DOI. The false, inaccurate, and misleading statements in the DOI served an obvious and critical purpose. In light of the high-profile controversy over the carcinogenicity of glyphosate, driven in large part by Monsanto, the company understood that the scientific community would have legitimate doubts as to the independence of a Monsanto-funded review effort. Assuaging these doubts was critical to the success of Monsanto's mission to discredit lARC's determination. This was accomplished in the summary review DOI by misrepresentation and omission. Intertek was presented as a firewall ensuring the freedom of panel members from Monsanto's influence. Monsanto was presented as entirely removed from the editorial process. However, as these emails reveal, Monsanto not only communicated directly with some Panel members, but the company paid them for their services directly - not solely through an intermediary. The company also reviewed and substantially edited the summary manuscript. Based on the DOI, readers and reviewers of the glyphosate summary review expected an objective assessment, with Intertek serving as a firewall to protect panelists from the financially-interested influence of the funder, Monsanto. This "firewall" was a cynical ploy. As a result, readers and reviewers were not given the opportunity to factor in Monsanto's substantial influence on the review - the critical purpose of a DOI.
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